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Salutaris Medical Devices announces 510(k) clearance

At Ophthalmology Futures European Forum 2015, Salutaris Medical Devices (SalutarisMD) announced that its SMD Sr90-1 Radionuclide Brachytherapy Source (RBS) received 510(k) clearance from the US Food and Drug Administration (FDA).

The SMD Sr90-1 RBS is indicated for episcleral brachytherapy of tumors and benign growths, and is intended for use within a manual brachytherapy applicator system.

Dr. Laurence Marsteller, CEO of SalutarisMD, observed, "reaching this important regulatory and commercial milestone further validates the company’s progress to date, and advances its clinical research agenda."

Dr. Marsteller’s presentation at Ophthalmology Futures European Forum 2015 also included a review of recent study results from the SalutarisMD investigational therapy for wet Age-related Macular Degeneration (AMD) utilizing a single dose of episcleral brachytherapy.

He concluded, "The study data are encouraging and bring us closer to offering this novel therapy, which is precise and customized, to patients."

SalutarisMD is a medical device company dedicated to developing minimally invasive, patient-centric treatments for vision loss.